| Registry | NCT02994082 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 123 (Actual) |
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| Sponsor | Mark Vander Weg (Fed); collaborators: Iowa City VA Health Care System |
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| Conditions | Smokeless Tobacco, Nicotine Dependence |
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| Interventions | Tailored behavioral intervention, Behavioral activation for elevated depressive symptoms, Post-cessation weight gain management, Alcohol use risk reduction, Nicotine replacement therapy - transdermal nicotine patch, Nicotine replacement therapy - nicotine lozenge, Nicotine replacement therapy - nicotine gum, Bupropion sustained release, Varenicline, Combination nicotine replacement therapy, Combination nicotine replacement therapy + bupropion, Tobacco quit line, Educational materials (Behavioral, drug) |
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| Dates | start 2016-12-01, primary completion 2019-09-01 (estimated), completion 2020-05-01 (estimated), first posted 2016-12-15, last updated 2019-07-24 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Smokeless Tobacco All trials for Nicotine Dependence All trials of Tailored behavioral intervention All trials of Behavioral activation for elevated depressive symptoms
-Summary
This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:
1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Tailored Intervention | Experimental | Behavioral: Tailored behavioral intervention; Behavioral: Behavioral activation for elevated depressive symptoms; Behavioral: Post-cessation weight gain management; Behavioral: Alcohol use risk reduction; Drug: Nicotine replacement therapy - transdermal nicotine patch; Drug: Nicotine replacement therapy - nicotine lozenge; Drug: Nicotine replacement therapy - nicotine gum; Drug: Bupropion sustained release; Drug: Varenicline; Drug: Combination nicotine replacement therapy; Drug: Combination nicotine replacement therapy + bupropion | The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences. |
| Facilitated tobacco quit line referral | Active comparator | Behavioral: Tobacco quit line; Behavioral: Educational materials | Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options. |
- Tailored behavioral intervention (Behavioral): Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.
- Behavioral activation for elevated depressive symptoms (Behavioral): Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
- Post-cessation weight gain management (Behavioral): Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
- Alcohol use risk reduction (Behavioral): Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
- Nicotine replacement therapy - transdermal nicotine patch (Drug), also known as Nicotine patch: Medication selection will be based on individual participant preferences, medical history, and contraindications.
- Nicotine replacement therapy - nicotine lozenge (Drug), also known as Nicotine lozenge: Medication selection will be based on individual participant preferences, medical history, and contraindications.
- Nicotine replacement therapy - nicotine gum (Drug), also known as Nicotine gum: Medication selection will be based on individual participant preferences, medical history, and contraindications.
- Bupropion sustained release (Drug), also known as Zyban: Medication selection will be based on individual participant preferences, medical history, and contraindications.
- Varenicline (Drug), also known as Chantix: Medication selection will be based on individual participant preferences, medical history, and contraindications.
- Combination nicotine replacement therapy (Drug): Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.
- Combination nicotine replacement therapy + bupropion (Drug), also known as Medication selection will be based on individual participant preferences, medical history, and contraindications.: Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.
- Tobacco quit line (Behavioral): Referral to the Department of Veterans Affairs tobacco telephone quit line.
- Educational materials (Behavioral): Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,
+Outcome measures
Primary outcomes
- Treatment satisfaction [Three month follow-up]: Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
Secondary outcomes
- Tobacco use [Three-and six-month follow-up]: At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.
- Alcohol use [Three- and six-month follow-up]: Alcohol use during the previous seven days.
- Depressive symptoms [Three- and six-month follow-up]: Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
- Body weight [Three- and six-month follow-up]: Body weight will be assessed via self-report.
- Enrollment rate [Six months after study initiation]: The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.
- Retention [Six months after study initiation]: The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.
- Treatment attendance [Three-month follow-up]: The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.
+Eligibility
Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers
Inclusion Criteria:
1. Use smokeless tobacco on a daily basis
2. Be willing to make a quit attempt in the next 30 days
3. Reside in a rural location
4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
5. Able to provide informed consent
6. Telephone access
7. Stable residence
Exclusion Criteria:
1. Planning to move in the next 12 months
2. Terminal illness
3. Unstable psychiatric disorder
4. Incarcerated
5. Institutionalized
+Locations (1)
| Facility | City | Country | Status |
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| Iowa City VA Healthcare System | Iowa City, Iowa | United States | |
+Investigators